FDA Officials Reveal More Than Just Forgotten Smallpox Samples in Storage Room

It was only hours after Congress interrogated the director of the Centers for Disease Control and Prevention about how the agency’s blunders with anthrax and bird flu, when other FDA officials revealed they had found more than just forgotten smallpox samples in a storage room on the National Institutes for Health campus in Maryland. The discovery also included 12 boxes and nearly 330 vials, which held a collection of dangerous pathogens, including the tropical disease dengue and the bacteria which causes spotted fever, stated the Food and Drug Administration.

Karen Midthun, who is director of the FDA’s Center for Biologics Evaluation and Research, told the media on Wednesday that the fact these materials were not discovered until the present time is completely unacceptable. She declared that the FDA takes the matter very seriously, and they are working hard to ensure that something such as this does not happen again.

The vials that contained smallpox, a blight responsible for over hundreds of millions of deaths, undoubtedly remain the greatest toxin discovered inside the NIH earlier this month. Those samples were flown to the CDC, where at least two were found to show growth in tissue cultures, which meant the samples were are viable or alive. Regardless the FDA’s confession on Wednesday about the nature and quantity of the other samples that had been discovered emphasized questions around the government’s ability to appropriately account for the amount of possibly deadly pathogens contained in its own labs.

Peter Marks, who is the deputy director of CBER, added that the boxes were in a seldom entered storage space. He stated that the reason why the samples had gone unnoticed for so long is something that the CBER is actively trying to find out. Their goal is to understand what happened and take the proper actions to make sure something like this never happens again.

The FDA stated that besides smallpox, dengue and spotted fever, the vials also contained organisms such as influenza and Q fever, which is a bacterium that could cause complications with the heart, liver and lungs. Agency officials explained that over 30 samples were demolished at one of the NIH facilities.

The FDA stated that investigators from different agencies are working to figure out the origins of the samples but that the collection was most likely assembled between the 1940’s and the 1960’s when standards for work with and storage of biological specimens were very different from those used today. FDA officials had said the hundreds of samples discovered earlier were in glass, heat-sealed flasks that had been well packed and showed no signs of leakage. They also stated there was no evidence that anyone had been exposed to the pathogens.

The FDA explained that it was in the process of revising its protocols and planned to put into place measures to safeguard that possibly hazardous samples were not overlooked in the future. In the meantime, the agency was going through various other storage areas to make sure there were not any more vials tucked away in forgotten areas.

This was because only hours after Congress interrogated the director of the Centers for Disease Control and Prevention about the agency’s blunders with anthrax and bird flu, other FDA officials revealed they had found more than just forgotten smallpox samples in a storage room on the National Institutes for Health campus in Maryland.